The Recall Desk
SevereFDA (Drugs)·D-444-2013·Announced 2013-05-29

Lloyd Inc. Recalls Thyro-Tab Tablets Due to Quality Failures

Lloyd Inc. of Iowa is recalling 5.7 million Thyro-Tab tablets because stability failures in previous lots make it impossible to verify the quality of the current lots.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant quality deviations that compromise product integrity are categorized as Severe.

Plain-English summary

Lloyd Inc. of Iowa is recalling 5,771,989 tablets of Lloyd Thyro-Tab 0.200 mg. The product was packaged in 150,000-tablet bulk drums for repackaging and is a prescription medication. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

The recall was initiated due to current good manufacturing practice (cGMP) deviations. Following a quality review of stability failures in previous lots, the firm determined there is insufficient data to confirm that the affected lots are not similarly impacted. The specific lots involved are HD29411 (Exp May-13), HE00512 (Exp Jul-13), and HF062122 (Exp Sep-13).

The bulk product was distributed to Forest Laboratories, Inc. in St. Louis, MO, which repackaged the tablets into 100-tablet bottles. These bottles were distributed to 75 customers nationwide and in Puerto Rico. Consumers with this medication should contact their healthcare provider or pharmacist for guidance on discontinuing use or obtaining a replacement.

The recalled product

Product
Lloyd Thyro-Tab 0.200 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Manufacturer
Lloyd Inc. of Iowa
Category
Drug — Prescription Medication
Hazard
Affected units
5,771,989

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot #: HD29411
  • Exp May-13
  • HE00512
  • Exp Jul-13
  • HF062122
  • Exp Sep-13.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 20 recalled by Lloyd Inc. of Iowa under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 20 products in this recall →

Related recalls

Same manufacturer · Lloyd Inc. of Iowa

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Same hazard · quality failure

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